Other Communications

hi HealthInnovations Update: February 3, 2014

hi HealthInnovations has discontinued its online hearing screening tests; instead, it advises consumers to request a hearing test from their doctor or to find an ENT doctor or audiologist. Hearing aids are still available for purchase online with prices ranging from $799 per aid to $999 per aid. The determination of which hearing aid is best for the consumer is based on the submission of an audiogram or hearing test taken within the last year. While the language contained on hi Health's website asks for an audiogram and urges physician consultation if the consumer notices sudden hearing loss or a medical condition, there is no FDA waiver language until after the consumer has placed an order. In our review of the site, we were able to select a hearing aid and proceed to the checkout for purchase before being informed of the FDA disclosure and waiver requirement and only then by clicking another link to actually read the waiver. There does not appear to be any mechanism in place to ensure the consumer actually reads the FDA disclosure statement before ordering the hearing aid.

hi HealthInnovations Update: May 28, 2012

On April 2, 2012, ASHA submitted a letter to CMS regarding the hearing test kit that hi HealthInnovations was disbursing to primary care physicians along with instructions to use CPT code 92552 for an automated hearing test.

CMS responded in a letter [PDF] dated May 22, 2012, indicating that they had discussions with UnitedHealthcare (UHC) and expressed concerns about future use of the online hearing test. In addition, they requested UHC inform CMS in advance if they receive FDA approval to put the test back up.

hi HealthInnovations Update: April 19, 2012

As a result of the combined efforts of the entire hearing health community and driven by the Hearing Industries Association, on March 28, 2012, the Food and Drug Administration issued a cease and desist letter to hi HealthInnovations [PDF] asking them to remove their online hearing "test." ASHA will continue to look for ways to help hi HealthInnovations understand the importance of including hearing health professionals in their program.

hi HealthInnovations Update: April 10, 2012

Unfortunately, hi HealthInnovations has reinstated its online hearing "test" and has not relabeled it as a screen. You can check out this information on the ASHA website if you have questions about the online sales of hearing aids.

hiHealthInnvations Update: April 9, 2012

ASHA learned today that hi HealthInnovations has taken its consumer hearing test off its website. According to hi HealthInnovations' consumer helpline, "enhancements" are being made to the test, with no available information about reactivation. hi HealthInnovations is advising consumers to seek a hearing test from an audiologist or otolaryngologist and submit the results online to receive a hearing aid. ASHA is optimistic that hi HealthInnovations has listened to the concerns of ASHA and other hearing health care organizations that have argued the hi HealthInnovations online hearing test has not been sufficiently validated.

hi HealthInnovations Update: February 17, 2012

Following a series of meetings and discussions with the senior leadership at hi HealthInnovations, we wanted to inform you that as of this date, we have not received any information from hi HealthInnovations indicating that they intend to change their business model in a way that protects patents' well-being or ensures effective hearing outcomes.

In January 2012, hi HealthInnovations began offering hearing aids over the Internet with no out-of-pocket costs to certain UnitedHealthcare Medicare Advantage members as well as direct-to-consumer hearing aids for people outside its network. A number of e-mail exchanges and two conference calls between ASHA staff and executives from hi HealthInnovations and UnitedHealthcare (UHC, a UnitedHealth Group company) in 2011 led to a January 31, 2012, meeting with hi HealthInnovations Chief Executive Officer Lisa Tseng, MD. At that meeting, ASHA representatives clearly stated our concerns, pointing out the past failures of similar device-driven models, and cited the lack of evidence that hi HealthInnovations's online hearing evaluation produces accurate results. Additional concerns that we stated included the lack of explicit information about the specific role that audiologists might play in the hi HealthInnovations program. To address this concern, ASHA representatives recommended that hi HealthInnovations's online "hearing test" be labeled a "hearing screen" that refers people who are suspected of having hearing loss to a certified audiologist.

Dr. Tseng agreed to provide ASHA with details about how audiologists will be included in the hi HealthInnovations service delivery model. Although hi HealthInnovations did provide additional information [PDF], it did not address the questions that ASHA raised as to the role that audiologists will play in the hi HealthInnovations program. ASHA also has learned that Jerry Yanz, a well-respected audiologist who was hired by hi HealthInnovations to help introduce the company's line of hearing products and services, has resigned after less than a month at the company.

Given the continuing lack of clarity about the role that audiologists could play in the UHC program, the lack of audiology leadership at hi HealthInnovations, and the failure to use a properly validated hearing assessment, ASHA remains deeply concerned about the potential risks to patients with hearing loss. If hi HealthInnovations does not address our recommendations, we will consider other ways to let legislators, regulators, and the general public know about the risks of this program. ASHA will also continue to work with other hearing health organizations to make sure we present a strong, unified position to all of our constituents. If you have information to share with the Food and Drug Administration (FDA), your state's attorney general, or your local office of consumer affairs about your experience with patients who have purchased hi HealthInnovations products, please contact one of these organizations at the following links:

ASHA encourages audiologists who have questions about hi HealthInnovations products or services or who encounter hi HealthInnovations beneficiaries seeking assistance with their hearing aids to contact Jennifer Stalpes, vice president of business strategy and development, hi HealthInnovations, at [email protected]. If you have questions for ASHA about this issue, please send an e-mail to [email protected].

hi HealthInnovations Update: February 3, 2012

We wanted to follow up with you regarding ASHA's ongoing discussions with hi HealthInnovations, a subsidiary of UnitedHealth Group, about their plans to offer hearing aids over the Internet with no out-of-pocket costs to certain UnitedHealth Medicare Advantage members as well as direct-to-consumer hearing aids for people outside their network.

Following two phone calls with executives at hi HealthInnovations and UnitedHealth Group, Lisa Tseng, CEO of hi HealthInnovations, and other members of UnitedHealth Group and hi HealthInnovations met with ASHA's Executive Director Arlene Pietranton, ASHA Chief Staff Officer for Audiology, Vic Gladstone, and other members of ASHA's staff at the National Office.

Though Dr. Tseng said that they intend to involve hearing-health professionals in their service-delivery process, they cannot yet describe how that process will work.

At the meeting, ASHA stressed a number of recommendations that we had already made to them in previous conversations and written communications. These include:

They should label and use their online hearing test as a screening tool to direct people who suspect they have hearing loss to a hearing-health professional.

They should expand their hearing benefit to include diagnostic and rehabilitation services of an audiologist.

They should consider working directly with audiologists so those who choose to do so can incorporate hi HealthInnovations hearing aids into their offerings for Medicare patients.

Dr. Tseng agreed that it would be helpful to both organizations to have further discussions. They also agreed to send ASHA the details of their program to include audiologists in their service-delivery model which we will share with members. In addition, they noted that they have a 45-day return policy for their hearing aids and asked that ASHA members who have questions about hi HealthInnovations products or services contact Jennifer Stalpes, vice president, strategy & business development at hi HealthInnovations at [email protected].

We will keep members updated as ASHA continues to gather information from hi HealthInnovations. If you have questions about this issue, please contact [email protected].

hi HealthInnovations Update: December 9, 2011

We wanted to follow up on the November 14 e-mail from Chief Staff Officer for Audiology Vic Gladstone regarding ASHA's discussions with hi HealthInnovations, a subsidiary of UnitedHealth Group, about their plans to offer hearing aids over the Internet with no out-of-pocket costs to certain UnitedHealth Medicare Advantage members in Florida as well as direct-to-consumer hearing aids for people outside their network.

ASHA had a second call with Dr. Lisa Tseng, CEO of hi HealthInnovations, and other members of UnitedHealth Group and hi HealthInnovations on December 1. During that call, ASHA stressed a number of points, including

the need to have a controlled listening environment when conducting hearing testing,

the key role of audiologists in any process that involves the fitting and dispensing of a hearing aid, and

the Association's continued interest in working with UnitedHealth Group and hi HealthInnovations to help them develop a hearing benefit that enables their members to get the most appropriate hearing services from qualified providers.

Dr. Tseng agreed that it would be helpful to both organizations to have further discussions. We will keep members updated as ASHA continues the dialogue with hi HealthInnovations and the FDA.

hi HealthInnovations Update: November 15, 2011

As many of you know, hi HealthInnovations, a subsidiary of UnitedHealth Group, has announced it will be offering hearing aids with no out-of-pocket costs to certain UnitedHealth Medicare Advantage members in Florida as well as direct-to-consumer hearing aids for people outside their network. Two weeks ago, to respond to this development, ASHA convened an internal team consisting of staff from audiology practices and health care economics units and our federal and state advocacy teams. Though ASHA continues to work on a variety of fronts - legislative, regulatory and through partnership with other audiology organizations, I want to update you about our activities so far.

Last week, members of the team had a conference call with Dr. Lisa Tseng, CEO of hi HealthInnovations. Dr. Tseng expressed their goal of providing more hearing-health services to underserved seniors and said they would like to create a win-win situation with patients and audiologists as they seek to provide their members with better health-care services. We told Dr. Tseng that we intend to do everything we can to make sure that audiologists and physicians are not bypassed in the hearing health care loop, and that consumers are effectively and safely served. Dr. Tseng strongly conveyed their intention to not short circuit the hearing-health delivery system, but, instead, to reach a population that has been unable to access services. Though we were not able to come to any agreement with Dr. Tseng, hi HealthInnovations has agreed to continue the dialogue with ASHA.

In addition, ASHA staff have been in contact with the Food and Drug Administration (FDA) to alert them of this offering and to clarify whether these sales comply with FDA guidelines. The FDA is reviewing the information we provided and has agreed to discuss this topic with us once they have completed their internal review.

We will keep members updated as we receive responses from hi HealthInnovations and the FDA and we will also continue to work with other audiology and physician organizations to develop a coordinated response.

ASHA is aware of the new audiology benefit offered by UnitedHealthcare (UHC), which would provide hearing aids to consumers via the Internet. The Association has convened an internal team consisting of staff from audiology professional practices and health care economics and advocacy units and our federal and state advocacy teams to act on the comprehensive strategies being developed. ASHA has identified various stakeholders and will meet with these groups over the next few weeks to convey the message that patient safety is paramount and that audiologists must be included in the diagnosis of hearing loss as well as the fitting of hearing aids.

We have also reached out to UHC and to the UHC subsidiary that is providing the benefit to ensure that we fully understand the details of the offering. Additionally, we intend to actively engage with other audiology organizations to develop a response that provides the following assurances:

Audiologists and physicians are not bypassed in the hearing health care loop.

Consumers are effectively and safely served.

Appropriate and necessary regulations are not bypassed by UHC's efforts.

We will keep members updated as we receive responses from UHC and implement our plans to work with other organizations in crafting a coordinated response. For questions, please contact [email protected].

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About Us

The American Speech-Language-Hearing Association (ASHA) is the national professional, scientific, and credentialing association for 186,000 members and affiliates who are audiologists; speech-language pathologists; speech, language, and hearing scientists; audiology and speech-language pathology support personnel; and students.